Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma
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| ClinicalTrials.gov Identifier: NCT00061048 |
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Recruitment Status :
Completed
First Posted : May 21, 2003
Results First Posted : June 8, 2011
Last Update Posted : October 31, 2012
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This study will examine the safety and effectiveness of Alemtuzumab (Campath-1H) for treating patients with adult T-cell leukemia/lymphoma (ATL). ATL is caused by a virus called human T-cell lymphotrophic virus type-1 (HTLV-1) that infects lymphocytes (white blood cells) called T-cells. Cancerous cells can be found not only in the blood, but also in the skin, lungs, lymph nodes, liver, bone, bone marrow, spleen, and meninges (tissues covering the brain). There are four categories of ATL, based on the aggressiveness of disease-smoldering, chronic, lymphoma, and acute. Campath-1H is a monoclonal antibody that attaches to and kills normal and cancerous lymphocytes, including T cells. Although Campath-1H is an experimental drug for treating ATL, it is approved by the Food and Drug Administration for treating chronic lymphocytic leukemia.
Patients 18 years of age and older with any type of ATL except smoldering may be eligible for this study. Candidates are screened with a medical history and physical examination, photos of skin lesions, measurement of lesions such as lymph nodes and skin nodules, blood and urine tests, electrocardiogram (EKG), chest x-ray, computed tomography (CT) scan or ultrasound of the abdomen, skin biopsy, bone marrow aspirate and biopsy, skin test, and lumbar puncture (spinal tap). Participants undergo treatment in two phases, as follows:
- Dose escalation phase: Patients receive an infusion of Campath-1H daily for three days. The initial dose is low and is increased daily as long as there are no side effects, or only mild reactions, until the patient is receiving the maximum dose of 30 milligrams per day.
- Stable dose phase: Patients receive infusions of Campath-1H 30 mg three times a week for up to 12 weeks.
In addition to treatment, patients are evaluated with the following tests and procedures:
- History and physical examination every 4 weeks.
- Blood tests every 4 weeks.
- CT scans to measure the size of the tumors every 4 weeks.
- Skin biopsies (if skin disease is present) and lymph note aspirates: Up to five biopsies and five aspirates may be taken to help diagnose the disease and evaluate the effect of Campath-1H on the cancer.
- Bone marrow biopsy: This procedure may be done to document or monitor disease progress.
Patients receive treatment for up to 12 weeks. Treatment may stop earlier if the patient achieves a complete response before the end of 12 weeks. Patients completing the study are followed periodically with a history and physical examination, blood and urine tests, tumor evaluation, skin biopsy and skin testing. They are seen monthly at first and then at 3-month intervals the first year; every 4 months the second year, every 6 months for the third through fifth years, and then yearly.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute T-Cell Leukemia-Lymphoma | Biological: Alemtuzumab | Phase 2 |
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 29 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of the Efficacy and Toxicity of Campath-1H in the Therapy of Adult T-Cell Leukemia |
| Study Start Date : | May 2003 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | July 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Campath-1H
Infusion of Campath-1H 3 mg on day # 1, 10 mg on day #2, and 30 mg day # 3 followed by maintenance Campath-1H 30 mg intravenously three times per week.
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Biological: Alemtuzumab
Infusion of Campath-1H 3 mg on day # 1, 10 mg on day #2, and 30 mg day # 3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment. |
- Overall Response Rate [ Time Frame: 60 months ]
Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition.
Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma.
Please see the protocol Link module for the full criteria if desired.
- Overall Survival [ Time Frame: 60 months ]Time between the first day of treatment to the day of death.
- Time to Progression [ Time Frame: 60 months ]Time between the first day of treatment to the day of disease progression which is defined as a persistent (at least two determinations) doubling of the peripheral blood leukemic cell count, the development of new lesions, or Ca elevations that are uncontrolled by conventional therapeutic procedures.
- Cell Surface Expression of CD52 on Tumor Cells [ Time Frame: 6 months ]The CD52 antibody-binding capacity (ABC) value is the measurement of the mean value of the maximum capacity of each cell to bind the anti-CD52 and when determined under conditions of saturating levels of antibody measures number of mean surface CD52 antigens per cell. CD52 ABC is negative when 100% saturation by therapeutic antibody is achieved.
- The Number of Participants With Adverse Events [ Time Frame: 18 months ]Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have serum antibodies directed to Human T-lymphotropic Virus Type 1 (HTLV-1).
- All patients must have a histologically confirmed diagnosis of adult T- cell leukemia/lymphoma and more than 10% of the malignant cells must express CD52 and CD25.
- All stages of Tac-expressing adult T-cell leukemia except smoldering are eligible: patients with chronic, lymphoma or acute Acute T-cell leukemia/lymphoma (ATL) are eligible.
- Patients must have measurable disease. All patients with greater than 10% abnormal (i.e. Tac homogeneous strongly expressing) peripheral blood mononuclear cell (PBMC)in the peripheral blood will be deemed to have measurable disease.
- The patient must have a granulocyte count of at least 100/mm(3) and a platelet count of greater than or equal to 50,000/mm(3).
- Patients must have a creatinine of less than 3.0 mg/dl.
- Omission of cytotoxic chemotherapy for ATL for 3 weeks prior to entry into the trial is required. However patients receiving a stable dose of corticosteroids for at least three to four weeks without evidence of tumor response will be eligible.
- Patients must have a life expectancy of greater than 2 months.
- Eligible patients must be greater than or equal to 18 years old. There is no upper age limit.
- Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) value less than or equal to 2.5-fold greater than the upper limit of normal and bilirubin less than or equal to 3.0/dl. If a liver function test is judged to be elevated due to the underlying ATL, this parameter will be considered an unevaluable parameter for toxicity determinations.
- Patients must be able to understand and sign an Informed Consent form.
- All patients must use adequate contraception during participation in this trial and for three months after completing therapy.
Exclusion Criteria:
- Patients with symptomatic leukemic meningitis will be excluded. However patients that have both ATL and another HTLV-1-associated disease, tropical spastic paraparesis (TSP) will be included.
- Pregnant and nursing patients are not eligible for the study. Because the effects of CAMPATH-1H on the developing fetus are unknown pregnant women will be excluded. Breast-feeding in patients with HTLV-1 infection is contraindicated because of the risk of transmission of the virus to the child. In addition, CAMPATH-1H may be present in breast milk and produce adverse events in the breast-feeding child.
- Human immunodeficiency virus (HIV) positive patients are excluded from the study. CAMPATH-1H may produce a different pattern of toxicities in patients with HIV infection and in addition the depletion of T cells produced by CAMPATH-1H may have adverse effects on HIV positive individuals.
- Patients with smoldering ATL are excluded.
- Patients with previously received Campath-1GH are ineligible.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061048
| United States, Maryland | |
| National Institutes of Health, National Cancer Institute | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Thomas A Waldmann, M.D. | NCI, NIH |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Thomas A. Waldmann, M.D., National Cancer Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00061048 |
| Obsolete Identifiers: | NCT00064155 |
| Other Study ID Numbers: |
030194 03-C-0194 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) ) 030194 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) ) |
| First Posted: | May 21, 2003 Key Record Dates |
| Results First Posted: | June 8, 2011 |
| Last Update Posted: | October 31, 2012 |
| Last Verified: | October 2012 |
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Monoclonal Antibody HTLV-1 CD52 Flow Cytometry |
Antibody Saturation Adult T-Cell Leukemia (ATL) ATL |
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Lymphoma Leukemia Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Alemtuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |